Unique Device Identifier

  • 0 ::
      • Customer_contacts ::
          • 0 ::
              • Phone : +1(800)633-8766
                • Email : Corporate.UDI@medtronic.com
          • Is_rx : true
            • Is_kit : false
              • Brand_name : PREMIERĀ® Anterior Cervical Plate System
                • Has_expiration_date : false
                  • Has_serial_number : false
                    • Has_lot_or_batch_number : true
                      • Is_single_use : true
                        • Is_otc : false
                          • Record_status : Published
                            • Is_labeled_as_no_nrl : false
                              • Device_count_in_base_package : 1
                                • Is_combination_product : false
                                  • Is_pm_exempt : false
                                    • Company_name : MEDTRONIC SOFAMOR DANEK, INC.
                                      • Mri_safety : Labeling does not contain MRI Safety Information
                                        • Commercial_distribution_status : In Commercial Distribution
                                          • Device_description : SCREW 6860020 VA SELF TAPPING 4.0X20MM
                                            • Sterilization ::
                                                • Is_sterilization_prior_use : true
                                                  • Sterilization_methods : Moist Heat or Steam Sterilization
                                                    • Is_sterile : false
                                                  • Device_sizes ::
                                                      • 0 ::
                                                          • Type : Outer Diameter
                                                            • Unit : Millimeter
                                                              • Value : 4.0
                                                            • 1 ::
                                                                • Type : Length
                                                                  • Unit : Millimeter
                                                                    • Value : 20.0
                                                              • Is_labeled_as_nrl : false
                                                                • Is_direct_marking_exempt : false
                                                                  • Version_or_model_number : 6860020
                                                                    • Has_donation_id_number : false
                                                                      • Has_manufacturing_date : false
                                                                        • Identifiers ::
                                                                            • 0 ::
                                                                                • Issuing_agency : GS1
                                                                                  • Type : Primary
                                                                                    • Id : 00681490482110
                                                                              • Is_hct_p : false
                                                                                • Gmdn_terms ::
                                                                                    • 0 ::
                                                                                        • Definition : An assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.
                                                                                          • Name : Bone-screw internal spinal fixation system, non-sterile
                                                                                    • Publish_date : 2015-08-19
                                                                                      • Product_codes ::
                                                                                          • 0 ::
                                                                                              • Code : KWQ
                                                                                                • Openfda ::
                                                                                                    • Regulation_number : 888.3060
                                                                                                      • Medical_specialty_description : Orthopedic
                                                                                                        • Device_class : 2
                                                                                                          • Device_name : Appliance, Fixation, Spinal Intervertebral Body
                                                                                                        • Name : APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY

Unique Device Identifier

  • 1 ::
      • Customer_contacts ::
          • 0 ::
              • Phone : +1(800)822-9637
                • Email : tech_support@edwards.com
          • Is_rx : true
            • Is_kit : true
              • Brand_name : SWAN-GANZ TRUE SIZE
                • Has_expiration_date : true
                  • Has_serial_number : false
                    • Catalog_number : 123F6P
                      • Has_lot_or_batch_number : true
                        • Is_single_use : true
                          • Is_otc : false
                            • Storage ::
                                • 0 ::
                                    • Special_conditions : STORE IN A COOL, DRY PLACE.
                                      • Type : Special Storage Condition, Specify
                                • Record_status : Published
                                  • Is_labeled_as_no_nrl : false
                                    • Device_count_in_base_package : 1
                                      • Is_combination_product : false
                                        • Is_pm_exempt : false
                                          • Company_name : Edwards Lifesciences LLC
                                            • Mri_safety : MR Safe
                                              • Commercial_distribution_status : In Commercial Distribution
                                                • Device_description : SWAN-GANZ TRUE SIZE MONITORING CATHETER DOUBLE LUMEN
                                                  • Sterilization ::
                                                      • Is_sterilization_prior_use : false
                                                        • Is_sterile : true
                                                      • Device_sizes ::
                                                          • 0 ::
                                                              • Text : EXTERIOR DIAMETER: 6F (2.0MM), USABLE LENGTH: 110 CM, RECOMMENDED GUIDEWIRE SIZE: 0.030 IN (0.76 MM), MINIMUM INTRODUCER SIZE: 7F (2.3 MM)
                                                                • Type : Device Size Text, specify
                                                          • Is_labeled_as_nrl : true
                                                            • Is_direct_marking_exempt : false
                                                              • Version_or_model_number : 123F6
                                                                • Has_donation_id_number : false
                                                                  • Has_manufacturing_date : false
                                                                    • Identifiers ::
                                                                        • 0 ::
                                                                            • Issuing_agency : GS1
                                                                              • Type : Primary
                                                                                • Id : 00690103000375
                                                                              • 1 ::
                                                                                  • Issuing_agency : GS1
                                                                                    • Unit_of_use_id : 00690103000375
                                                                                      • Package_status : In Commercial Distribution
                                                                                        • Quantity_per_package : 5
                                                                                          • Type : Package
                                                                                            • Id : 50690103000370
                                                                                      • Is_hct_p : false
                                                                                        • Gmdn_terms ::
                                                                                            • 0 ::
                                                                                                • Definition : A flexible tube with an inflatable balloon at its distal tip designed to deliver an indicator solution (e.g., saline or dextrose), at a temperature lower than the blood in the heart, to measure and monitor cardiac output and other haemodynamic parameters using thermodilution techniques. It includes an exit port for the indicator solution and an electrical component (e.g., a thermistor) in which resistance varies in proportion to the temperature at the distal tip. This device is connected to an appropriate external thermal dilution unit. This is a single-use device.
                                                                                                  • Name : Pulmonary artery catheter, thermal dilution
                                                                                            • Publish_date : 2016-09-03
                                                                                              • Product_codes ::
                                                                                                  • 0 ::
                                                                                                      • Code : DYG
                                                                                                        • Openfda ::
                                                                                                            • Regulation_number : 870.1240
                                                                                                              • Medical_specialty_description : Cardiovascular
                                                                                                                • Device_class : 2
                                                                                                                  • Device_name : Catheter, Flow Directed
                                                                                                                • Name : CATHETER, FLOW DIRECTED
                                                                                                              • 1 ::
                                                                                                                  • Code : DQE
                                                                                                                    • Openfda ::
                                                                                                                        • Regulation_number : 870.1230
                                                                                                                          • Medical_specialty_description : Cardiovascular
                                                                                                                            • Device_class : 2
                                                                                                                              • Device_name : Catheter, Oximeter, Fiber-Optic
                                                                                                                            • Name : CATHETER, OXIMETER, FIBEROPTIC
                                                                                                                          • 2 ::
                                                                                                                              • Code : KRA
                                                                                                                                • Openfda ::
                                                                                                                                    • Regulation_number : 870.1210
                                                                                                                                      • Medical_specialty_description : Cardiovascular
                                                                                                                                        • Device_class : 2
                                                                                                                                          • Device_name : Catheter, Continuous Flush
                                                                                                                                        • Name : Catheter, continuous flush
                                                                                                                                      • 3 ::
                                                                                                                                          • Code : DQO
                                                                                                                                            • Openfda ::
                                                                                                                                                • Regulation_number : 870.1200
                                                                                                                                                  • Medical_specialty_description : Cardiovascular
                                                                                                                                                    • Device_class : 2
                                                                                                                                                      • Device_name : Catheter, Intravascular, Diagnostic
                                                                                                                                                    • Name : CATHETER, INTRAVASCULAR, DIAGNOSTIC

Unique Device Identifier

  • 2 ::
      • Customer_contacts ::
          • 0 ::
              • Phone : +1 519 895 0100
                • Email : Quality@unitron.com
          • Is_rx : false
            • Is_kit : false
              • Brand_name : Unitron
                • Has_expiration_date : false
                  • Has_serial_number : true
                    • Catalog_number : 063-5665-01
                      • Has_lot_or_batch_number : false
                        • Is_single_use : false
                          • Is_otc : false
                            • Record_status : Published
                              • Is_labeled_as_no_nrl : false
                                • Device_count_in_base_package : 1
                                  • Is_combination_product : false
                                    • Is_pm_exempt : true
                                      • Company_name : Unitron Hearing Ltd
                                        • Mri_safety : MR Unsafe
                                          • Commercial_distribution_status : In Commercial Distribution
                                            • Device_description : Quantum2 20 Micro CIC
                                              • Sterilization ::
                                                  • Is_sterilization_prior_use : false
                                                    • Is_sterile : false
                                                  • Is_labeled_as_nrl : false
                                                    • Is_direct_marking_exempt : true
                                                      • Version_or_model_number : 063-5665-01
                                                        • Has_donation_id_number : false
                                                          • Has_manufacturing_date : true
                                                            • Identifiers ::
                                                                • 0 ::
                                                                    • Issuing_agency : GS1
                                                                      • Type : Primary
                                                                        • Id : 00698764501101
                                                                  • Is_hct_p : false
                                                                    • Gmdn_terms ::
                                                                        • 0 ::
                                                                            • Definition : A battery-powered acoustic device intended to compensate for impaired hearing by transmitting amplified sound waves to the eardrum through air. It typically consists of a miniature microphone, amplifier, and speaker (receiver) in a case that fits the ear canal [in-the-canal (ITC)] or in a case nearly hidden in the ear canal [completely-in-the-canal (CIC)]. The microphone receives sound waves and converts them into electrical signals which are increased by the amplifier and sent as sound waves, by the speaker, to the eardrum. It is used for mild to moderately-severe hearing loss; most types are programmable to enable computerized adjustments for a patient's hearing loss and related factors.
                                                                              • Name : Canal air-conduction hearing aid
                                                                        • Publish_date : 2016-09-12
                                                                          • Product_codes ::
                                                                              • 0 ::
                                                                                  • Code : ESD
                                                                                    • Openfda ::
                                                                                        • Regulation_number : 874.3300
                                                                                          • Medical_specialty_description : Ear, Nose, Throat
                                                                                            • Device_class : 1
                                                                                              • Device_name : Hearing Aid, Air Conduction
                                                                                            • Name : Hearing aid, air conduction

Unique Device Identifier

  • 3 ::
      • Customer_contacts ::
          • 0 ::
              • Phone : +1(800)456-7779
                • Ext : 1
                  • Email : Customer.Service@osteomed.com
            • Is_rx : true
              • Is_kit : false
                • Brand_name : OsteoMed
                  • Has_expiration_date : true
                    • Has_serial_number : false
                      • Catalog_number : 813-1345-SP
                        • Has_lot_or_batch_number : true
                          • Is_single_use : true
                            • Is_otc : false
                              • Storage ::
                                  • 0 ::
                                      • Special_conditions : Store at controlled room temperature out of direct sunlight
                                        • Type : Special Storage Condition, Specify
                                  • Record_status : Published
                                    • Is_labeled_as_no_nrl : false
                                      • Device_count_in_base_package : 1
                                        • Is_combination_product : false
                                          • Is_pm_exempt : false
                                            • Company_name : OSTEOMED LLC
                                              • Mri_safety : Labeling does not contain MRI Safety Information
                                                • Commercial_distribution_status : In Commercial Distribution
                                                  • Device_description : PrimaLIF LLIF PEEK Implant, 13mm X 22mm X 45mm, Parallel, Sterile
                                                    • Sterilization ::
                                                        • Is_sterilization_prior_use : false
                                                          • Is_sterile : true
                                                        • Device_sizes ::
                                                            • 0 ::
                                                                • Type : Length
                                                                  • Unit : Millimeter
                                                                    • Value : 45
                                                              • Is_labeled_as_nrl : false
                                                                • Is_direct_marking_exempt : true
                                                                  • Version_or_model_number : 813-1345-SP
                                                                    • Has_donation_id_number : false
                                                                      • Has_manufacturing_date : false
                                                                        • Identifiers ::
                                                                            • 0 ::
                                                                                • Issuing_agency : GS1
                                                                                  • Type : Primary
                                                                                    • Id : 00845694046121
                                                                              • Is_hct_p : false
                                                                                • Gmdn_terms ::
                                                                                    • 0 ::
                                                                                        • Definition : A sterile collection of small sheets of firm material and bone screws intended to be implanted onto fractured bone fragments to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the components are made of a material that is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Tools for implantation may be included. The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion).
                                                                                          • Name : Orthopaedic fixation plate kit, non-bioabsorbable, sterile
                                                                                    • Publish_date : 2015-05-22
                                                                                      • Product_codes ::
                                                                                          • 0 ::
                                                                                              • Code : MAX
                                                                                                • Openfda ::
                                                                                                    • Regulation_number : 888.3080
                                                                                                      • Medical_specialty_description : Orthopedic
                                                                                                        • Device_class : 2
                                                                                                          • Device_name : Intervertebral Fusion Device With Bone Graft, Lumbar
                                                                                                        • Name : Intervertebral fusion device with bone graft, lumbar

Unique Device Identifier

  • 4 ::
      • Customer_contacts ::
          • 0 ::
              • Phone : +1(800)456-7779
                • Ext : 1
                  • Email : Customer.Service@osteomed.com
            • Is_rx : true
              • Is_kit : false
                • Brand_name : OsteoMed
                  • Has_expiration_date : false
                    • Has_serial_number : false
                      • Catalog_number : 231-2825
                        • Has_lot_or_batch_number : true
                          • Is_single_use : true
                            • Is_otc : false
                              • Record_status : Published
                                • Is_labeled_as_no_nrl : false
                                  • Device_count_in_base_package : 1
                                    • Is_combination_product : false
                                      • Is_pm_exempt : false
                                        • Company_name : OSTEOMED LLC
                                          • Mri_safety : Labeling does not contain MRI Safety Information
                                            • Commercial_distribution_status : In Commercial Distribution
                                              • Device_description : Prebent Recon, Locking, MD, Left
                                                • Sterilization ::
                                                    • Is_sterilization_prior_use : true
                                                      • Sterilization_methods : Moist Heat or Steam Sterilization
                                                        • Is_sterile : false
                                                      • Device_sizes ::
                                                          • 0 ::
                                                              • Type : Height
                                                                • Unit : Millimeter
                                                                  • Value : 2.8
                                                            • Is_labeled_as_nrl : false
                                                              • Is_direct_marking_exempt : true
                                                                • Version_or_model_number : 231-2825
                                                                  • Has_donation_id_number : false
                                                                    • Has_manufacturing_date : true
                                                                      • Identifiers ::
                                                                          • 0 ::
                                                                              • Issuing_agency : GS1
                                                                                • Type : Primary
                                                                                  • Id : 00845694091770
                                                                            • Is_hct_p : false
                                                                              • Gmdn_terms ::
                                                                                  • 0 ::
                                                                                      • Definition : A collection of small sheets of firm material and bone screws, of various shapes/sizes, that are implanted onto fractured craniofacial bone (including the maxilla and/or mandible) to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the components are made of a material that is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Tools for implantation may be included. The device may also be used for craniofacial reconstructive procedures (e.g., to treat congenital malformations), endobrow fixation, or craniotomy flap fixation.
                                                                                        • Name : Craniofacial fixation plate kit, non-bioabsorbable
                                                                                  • Publish_date : 2015-12-11
                                                                                    • Product_codes ::
                                                                                        • 0 ::
                                                                                            • Code : JEY
                                                                                              • Openfda ::
                                                                                                  • Regulation_number : 872.4760
                                                                                                    • Medical_specialty_description : Dental
                                                                                                      • Device_class : 2
                                                                                                        • Device_name : Plate, Bone
                                                                                                      • Name : PLATE, BONE